Intelligent Bio Solutions (INBS) begins 510(k) clinical study for codeine drug screening system

Rhea-AI Filing Summary

Intelligent Bio Solutions Inc. announced that it has started a clinical study program to support a new FDA 510(k) submission seeking U.S. market clearance for its Intelligent Fingerprinting Drug Screening System to detect the opiate codeine. The update was shared via a furnished press release attached as an exhibit.

Insights

Healthcare regulatory and diagnostics analyst

Intelligent Bio Solutions starts clinical work toward FDA 510(k) clearance for codeine detection.

Intelligent Bio Solutions has begun a clinical study program to back an FDA 510(k) submission for U.S. clearance of its Intelligent Fingerprinting Drug Screening System targeting the opiate codeine. This signals an active push to enter or expand in the U.S. clinical drug screening market.

The 510(k) pathway typically requires demonstrating that a device is substantially equivalent to a legally marketed predicate. Launching a clinical study program is a key step in generating the data needed for that comparison, particularly when dealing with controlled substances such as codeine.

The outcome and timing of the 510(k) process are not detailed here, and no financial figures are provided. Future company communications describing study results or the status of the 510(k) submission will be important for understanding how this initiative may influence adoption of the codeine test in U.S. settings.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): January 28, 2026

INTELLIGENT BIO SOLUTIONS INC.

(Exact name of registrant as specified in its charter)

Delaware		001-39825		82-1512711
(State of Incorporation)		(Commission File Number)		(IRS employer identification no.)

135 West, 41st Street, 5th Floor

New York, NY 10036

(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code: (646) 828-8258

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.01 par value		INBS		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On January 28, 2026, Intelligent Bio Solutions Inc. (the “Company”) issued a press release (the “Press Release”) announcing the commencement of its clinical study program to support its new FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine. A copy of the Press Release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. The foregoing disclosure is qualified in its entirety by the full text of the Press Release.

The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for the purpose of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated by reference.

Item 9.01 Financial Statements and Exhibits.

No.		Description
99.1		Press Release, dated January 28, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 28, 2026
	INTELLIGENT BIO SOLUTIONS INC.
	By:	/s/ Spiro Sakiris
	Name:	Spiro Sakiris
	Title:	Chief Financial Officer

FAQ

What did Intelligent Bio Solutions (INBS) announce in this 8-K filing?

Intelligent Bio Solutions announced it has started a clinical study program to support an FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detecting the opiate codeine, as described in an attached press release dated January 28, 2026.

What product is Intelligent Bio Solutions (INBS) studying for FDA 510(k) clearance?

The company is studying its Intelligent Fingerprinting Drug Screening System, specifically for detecting the opiate codeine. The clinical study program is intended to generate data supporting a new FDA 510(k) submission aimed at obtaining U.S. market clearance for this codeine detection application.

Which FDA pathway is Intelligent Bio Solutions (INBS) pursuing for its codeine test?

Intelligent Bio Solutions is pursuing the FDA 510(k) pathway, which involves demonstrating substantial equivalence to an existing legally marketed device. The clinical study program mentioned in the filing is designed to support this 510(k) submission for U.S. market clearance of its codeine drug screening system.

Does the Intelligent Bio Solutions (INBS) 8-K include financial results or earnings data?

The 8-K does not present financial results or earnings data. It focuses on a corporate update: the start of a clinical study program to back an FDA 510(k) submission for U.S. market clearance of the Intelligent Fingerprinting Drug Screening System for detecting the opiate codeine.

How is the information about the Intelligent Bio Solutions (INBS) clinical study provided to investors?

The company furnished the information under Regulation FD by referencing a press release attached as Exhibit 99.1. That press release, dated January 28, 2026, contains details on starting the clinical study program for the FDA 510(k) submission related to codeine detection.

Is the Intelligent Bio Solutions (INBS) press release in this 8-K considered filed or furnished?

The press release attached as Exhibit 99.1 is described as furnished, not filed, under the Securities Exchange Act of 1934. It is not automatically incorporated by reference into other Securities Act or Exchange Act filings unless specifically identified as such there.